Plain English Summary

Background and study aims Heavy menstrual bleeding (HMB) is a very common and distressing condition which affects over 1.5 million women in the UK. It is responsible for one in 20 women consulting their general practitioner (GP) and accounts for 20% of hospital referrals in gynaecology. Initial treatment usually involves the use of drugs, including the combined oral contraceptive pill, as well as a hormone-impregnated intrauterine contraceptive device. However, these may be unsuitable or unsuccessful in some women, who will need surgical treatment. The main aim of this study is to compare the clinical and cost effectiveness of two different surgical treatments: laparoscopic supra-cervical hysterectomy (LASH) and endometrial ablation (EA) for the treatment of HMB.

Who can participate? Women less than 50 years of age with heavy menstrual bleeding (HMB) eligible for surgical treatment can take part.

What does the study involve? Eligible women will be randomly allocated to undergo either LASH or EA. All participants will be asked to complete assessment questionnaires at certain time points - before surgery and again at 6 weeks, 6 and 12 months after surgery. Women will also complete a 14-day diary immediately after their operation and a simple questionnaire at 4 weeks after surgery.

What are the possible benefits and risks of participating? Participants may not benefit personally from taking part in the study but will be directly helping us to generate information which could help plan more effective treatment for women with heavy periods. We do not think that there are any additional risks or disadvantages to participating in this study. Whichever group participants are allocated to, their care will be overseen by an experienced consultant gynaecologist. Steps are always taken to make sure that any possible risks are minimised. As part of routine care, participants will be well informed of potential risks.

Acronym

HEALTH

Study hypothesis

The hypothesis being tested is that laparoscopic supra-cervical hysterectomy is superior to second generation endometrial ablation for the treatment of heavy menstrual bleeding (HMB) in terms of patient satisfaction, quality of life (QoL) and costs.

Ethics approval

North of Scotland Research Ethics Service Committee 2, 06/01/2014, ref. 13/NS/0155

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Heavy menstrual bleeding

Intervention

The patients are randomised to two groups.The interventions being compared are: 1. Laparoscopic supra-cervical hysterectomy (LASH): The LASH procedure involves removing the part of your womb that causes menstrual bleeding. This is done by keyhole surgery. Three small cuts on the stomach wall are made. The procedure is done under a general anaesthetic and patients are usually home within 24 hours of the operation. As the cervix is not removed, women still need to have cervical smears in the future.2. Endometrial ablation (EA): The EA procedure involves placing a thin device in the womb by passing it first through the vagina and then through the cervix. The lining of the womb is destroyed and the device is then removed. EA is done as a day case procedure in hospital. It is usually done under a general anaesthetic but can be under local anaesthetic if preferred. As the uterus is not removed women still need cervical smears in the future.

Clinical1. Duration of operation2. Peri-operative complications and recovery details including analgesia requirements3. Time to discharge4. Further gynaecological surgery by 12 months

EconomicWider societal costs associated with changes in productivity based on information on the time taken to return to normal activities (following intervention) combined with questions on work productivity delivered during the follow-up period. Further, a simple Markov model, based on within trial data supplemented by available published data on the requirement for further gynaecological surgery over time (following the alternative procedures) will be developed and used to extrapolate cost-effectiveness beyond 12 months.

Overall trial start date

01/01/2014

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women less than 50 years of age with heavy menstrual bleeding eligible for endometrial ablation2. Women who are willing to be randomised between laparoscopic supra-cervical hysterectomy and endometrial ablation